End-expiratory Transpulmonary Pressure-guided vs Electrical Impedance Tomography-guided PEEP Titration Methods in Patients With Intra-abdominal Hypertension Combined With Acute Respiratory Distress Syndrome: a Randomized Crossover Controlled Study

End-expiratory Transpulmonary Pressure-guided vs EIT-guided PEEP Titration Methods in Patients With Intra-abdominal Hypertension Combined With Acute Respiratory Distress Syndrome: a Randomized Crossover Controlled Study

This study aims to adopt a randomized crossover design to compare the effects of end-expiratory transpulmonary pressure-guided PEEP titration and EIT-guided PEEP titration on local lung ventilation, shunt, dead space, and ventilation-perfusion (V/Q) ratio as monitored by EIT. Additionally, it will evaluate their impact on respiratory mechanics, chest wall mechanics, mechanical power, hemodynamics, gas exchange, intra-abdominal pressure, abdominal perfusion pressure, and renal perfusion. By identifying an optimal PEEP titration strategy for patients with intra-abdominal hypertension (IAH) and acute respiratory distress syndrome (ARDS), this study aims to develop a mechanical ventilation approach that maintains lung recruitment and minimizes lung injury while avoiding adverse effects on other organs. The findings could facilitate the clinical application of this strategy and benefit a broader population of patients with IAH and ARDS.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome (ARDS); Intra-abdominal Hypertension
• Intervention / Treatment: Other: Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients; Other: EIT-Guided PEEP Titration in IAH and ARDS Patients

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaojing Professor; Phone Number: 13995518630; Email: 13995518630@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Union Hospital
      • Contact: Xiaojing Zou; Phone Number: 13995518630; Email: 13995518630@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. age: 18-80 years;
2. meets IAH ≥12 mmHg;
3. meets the diagnostic criteria of the new global definition of ARDS in the 2023 edition;
4. PaO2/FiO2 ≤ 150;
5. within 36 hours of invasive mechanical ventilation;
6. patients or their family members were consulted, agreed to participate in the trial, and signed an informed consent form.

Exclusion Criteria:

1. Age <18 years or age >80 years;
2. uncorrected shock of any type;
3. chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, right heart failure, pulmonary hypertension, or severe cardiac arrhythmia;
4. pneumothorax or bronchopleural fistula or lobectomy or other surgery of the lungs within 2 weeks of surgery;
5. non-invasive ventilation or transnasal high-flow oxygen;
6. with relevant contraindications to the application of EIT (large chest skin injuries, infections, pacemaker implanters, in vivo automatic defibrillator implantation, etc.) pneumothorax, mediastinal emphysema, massive pleural effusion;
7. oesophageal obstruction, oesophageal perforation, severe oesophageal variceal bleeding, upper gastrointestinal surgery, and other factors that make it impossible to place an oesophageal pressure catheter;
8. diaphragmatic hernia, thoracic deformity; patients with obvious pulmonary hernias;
9. prolongation of prothrombin time (PT), activated partial thromboplastin time (APTT) to two times the high limit of normal values or with active bleeding in the nasopharynx;
10. severe neurological disease: intracranial hypertension or neuromuscular disease, etc;
11. pregnant and lactating women;
12. patients to be treated with ECMO;
13. re-admission to the ICU of patients who have already been included in this study, or who are participating in other clinical studies;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transpulmonary Pressure-Guided PEEP Titration	Other: Transpulmonary Pressure-Guided PEEP Titration in IAH and ARDS Patients; After completion of baseline ventilation and lung recruitment, the ventilator was switched to volume-controlled mode, and PEEP was set using an empirical PL-FiO₂ table, with the goal of maintaining end-expiratory transpulmonary pressure (PL) > 0 cmH₂O and end-inspiratory PL ≤ 20 cmH₂O.
Experimental: EIT-Guided PEEP Titration	Other: EIT-Guided PEEP Titration in IAH and ARDS Patients; After completion of baseline ventilation and lung recruitment, the ventilator was switched to pressure-controlled mode with a pressure control (PC) of 15 cmH₂O. PEEP was initially set at 35 cmH₂O and then gradually decreased in steps of 3 cmH₂O, with each PEEP level maintained for 2 minutes, down to a minimum of 2 cmH₂O, using the ODCL method for PEEP titration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between the optimal PEEP titrated based on end-expiratory transpulmonary pressure and that guided by EIT	After PEEP titration

Secondary Outcome Measures

Outcome Measure	Time Frame
Electrical impedance tomography (EIT) parameters included: Global inhomogeneity (GI) index、Center of ventilation (CoV)、Shunt fraction、V/Q matching ,and so on	30-minute ventilation after PEEP titration
Clinical respiratory and hemodynamic parameters	30-minute ventilation after PEEP titration

Collaborators and Investigators

• Sponsor: XiaoJing Zou,MD

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Compartment Syndromes; Respiratory Distress Syndrome; Intra-Abdominal Hypertension
• Other Study ID Numbers: PEEP20240921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No